Due to the different dates of application of the new EU regulations, the regulation of medical devices and that of IVD devices differ somewhat from one another during the transitional period.
According to Regulations (EU) 2017/745 and (EU) 2017/746, a medical device economic operator means a manufacturer, a system/procedure pack manufacturer, an authorised representative, an importer, or a distributor.
- Manufacturer is an operator who manufactures a device or has a device manufactured and markets that device under its name or trade mark.
- Authorised representative is an operator who is responsible for certain responsibilities of a non-EU manufacturer in the EU area.
- Importer is an operator based in the EU area who imports products from outside the EU into the EU market.
- Distributor supplies devices to other operators or consumers in Finland. A distributor may import equipment from the EU area or from domestic operators.
- System/procedure pack assembler is an operator who places procedure packs and/or systems on the EU market.
The duties of an authorised representative, importer and distributor are defined in Articles 11, 13 and 14 of Regulations (EU) 2017/745 and (EU) 2017/746.
Section 49 of the national Act (719/2021) specifies the distributor liable to file a notification as follows: distributes products to retailers or directly to professional users. A Fimea Administrative Regulation has been issued on the liability to file a notification.
For IVD devices, the regulation pertaining to operators, such as distributors and importers, is, for the time being, set out in a national act (629/2010).
Operator means a natural or legal person who is responsible for import to Finland, sale, rental or other distribution of a healthcare device, whether in return of payment or free of charge, or who professionally installs or maintains medical devices. (629/2010) Section §17 defines the operator's obligations:
- The operator shall comply with the information and instructions provided by the manufacturer on the transportation, storage, installation, servicing and other handling of the medical device.
- The operator shall ensure that, when handing over the medical device to the end user, the device is in the condition in which the manufacturer intended the device to be used. A device handed over to an end user other than a professional user shall, where necessary, be properly serviced before it is handed over.
- The operator shall notify the manufacturer or authorised representative of any adverse incidents it has become aware of that have been confirmed, or are suspected of, having resulted from a defect or shortcoming in the device.
- Provisions on the obligation to notify are laid down in section 18 of the Act. Read more about the obligations to notify concerning different operators.
However, in the case of a device placed on the market under the IVD Regulation, the requirements of the IVD Regulation shall also apply to operators.
About repackaging and making of translations (MDR/IVDR, Article 16):
A distributor, importer or other natural or legal person shall assume the obligations incumbent on manufacturers if it does any of the following:
- makes available on the market a device under its name, registered trade name or registered trade mark;
- changes the intended purpose of a device already placed on the market or put into service;
- modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected.
Provision, including translation, of the information supplied by the manufacturer relating to a device already placed on the market and of further information which is necessary in order to market the device in the relevant Member State shall not be considered as a modification of a device.
Changes to the outer packaging and pack size of a device are possible if the original condition of the device is not affected. In the case of sterile devices in particular, attention shall be paid to the packaging layer that is necessary for maintaining the sterile condition, the opening of which is considered to have an adverse effect on the original condition of the device.
If the distributor repackages or modifies the device, it shall indicate the activity carried out on the device or device packaging. In addition, the distributor shall indicate its name, registered trade name or registered trade mark, registered place of business and the address at which it can be contacted, so that its location can be established.
Distributors and importers shall ensure that they have a quality management system in place which includes procedures for ensuring that the translation of information is accurate and up-to-date, the original condition of the device is preserved, and the packaging of the repackaged device is not defective, of poor quality or untidy.
The quality management system shall cover, inter alia, procedures ensuring that the distributor or importer is informed of any corrective action taken by the manufacturer in relation to the device in question in order to respond to safety issues or to bring it into conformity with this Regulation.
The operator shall, at least 28 days prior to making the relabelled or repackaged device available on the market:
- inform the manufacturer and the national competent authority of the intention to make the relabelled or repackaged device available;
- upon request, provide the manufacturer and the competent authority with a sample or mock-up of the relabelled or repackaged device, including any translated label and instructions for use;
- submit to the competent authority a certificate, issued by a notified body, attesting that the quality management system complies with the requirements imposed on it.